Senior Device Quality Engineer III

Job Description

About This Role

This is a senior level position that is responsible for the quality oversight of design control and risk management activities for combination products and medical devices. This individual will work closely with the device development teams and medical device suppliers and testing partners during the device design/development phases with supportive responsibilities throughout the device lifecycle. In addition, this role will provide oversight for the development, implementation, and continuous improvement of device-related quality processes and procedures and ensure compliance to the relevant standards and regulatory requirements for devices and combination products.

WhatYou’llDo
  • Lead Quality Engineering guidance and oversight for medical device and combination products during feasibility, all phases of design control, risk management, human factor/usability engineering, process development and verification/validation testing
  • Lead Quality review and approval of all technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. through applicable company procedures and regulatory requirements
  • Support Asset Team and strategy for filing and implementing changes through authoring and/or reviewing sections of filing applicable to design control, risk management and specification and supporting responses to regulatory questions
  • Lead or support sustainable, continuous improvement to the device and combination product Quality Management System
  • Manage QA interface with medical device or device component suppliers and testing partners by providing technical and quality support during the development, testing and manufacture at a supplier site


Qualifications

Who YouAre

You are the primary Quality representative for medical device and combination product development for use with Biogen therapies across all modalities within PO&T. You’re responsible for adherence to regulatory requirements and internal policies and procedures to ensure product quality, integrity, and compliant development and marketed product.

Required Skills
  • Minimally BA/BS in Engineering (Biomedical/Mechanical Engineering) with 5+years of relevant industry experience required.
  • Medical Device and Development Experience
  • Ability to work cross-functionally and independently
  • Project management skills
  • Familiarity with relevant regulatory and standards for medical device development




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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